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FDA 510(k)

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS

K-Number: K243473 · 2025-07-29

ApplicantPrognosys Medical Systems Private Limited
Decision Date2025-07-29
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is a medical device manufactured by Prognosys Medical Systems Private Limited. It received FDA 510(k) clearance on 2025-07-29 under approval number K243473. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is a medical device that received FDA 510(k) clearance on 2025-07-29. It is manufactured by Prognosys Medical Systems Private Limited. The 510(k) number is K243473.

When was PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS approved by the FDA?

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS received FDA 510(k) clearance on 2025-07-29, under approval number K243473.

What company makes PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is manufactured by Prognosys Medical Systems Private Limited.

What is the FDA product code for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

The FDA product code for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is IZL.

Other Devices by Prognosys Medical Systems Private Limited

K183541ProRad 2FC and ProRad 3NC Stationary Radiographic Systems K240771PRORAD X-Ray Flat Panel Detector with DROC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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